Acumed LLC Recall 89771
Description: 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
Acumed LLC Recall 89771 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0958-2022 |
| Event ID | 89771 |
| Event Description | 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, Puerto Rico and the country of South Africa. |
| Quantity | 537 units |
| Recall Reason | Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage. |
| Device Classification | 20220427 |
| Device Code Info | All Batch number distributed between 22 AUG 2018 to 07 FEB 2022 . UDI : 10806378022869 |
| Center Classification Date | 20220420 |
| Recall Initiation Date | 20220309 |
| Recalling Firm | Acumed LLC |
| Initial Notification | Letter |
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